Smoking Clinical Trial
Official title:
The Effect of Synbiotic Tablet Usage on the Clinical and Biochemical Parameters in Smokers and Nonsmokers With Gingivitis: A Randomized Placebo-Controlled Clinical Trial
Verified date | February 2018 |
Source | Kirikkale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the efficacy of oral administration of synbiotic tablets
on the clinical parameters and the levels of selected inflammatory mediators in gingival
crevicular fluid (GCF) in smokers and non-smokers with gingivitis.
This study designed as a double-blind randomized placebo-controlled clinical trial.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 29, 2015 |
Est. primary completion date | June 29, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Systemically healthy subjects - Clinical diagnosis of gingivitis Exclusion Criteria: - Subjects who had used any systemic antibiotics in the previous 3 months, - Subjects who had used a product containing probiotics in the previous month - Systemic disease or condition that could interfere with the study results - Ongoing drug therapy that could affect the signs of gingivitis - Subjects who were received periodontal treatment in the last 6 months and - Allergic to milk and milk products |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kirikkale University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Interleukin (IL)-6 level of GCF at 2 months | GCF samples were collected with paper strips and IL-6 levels of GCF were measured using commercial kits by using ELISA method | baseline, 1st and 2nd months | |
Primary | Change from Baseline IL-8 level of GCF at 2 months | GCF samples were collected with paper strips and IL-8 levels of GCF were measured using commercial kits by using ELISA method | baseline, 1st and 2nd months | |
Primary | Change from Baseline IL-10 level of GCF at 2 months | GCF samples were collected with paper strips and IL-10 levels of GCF were measured using commercial kits by using ELISA method | baseline, 1st and 2nd months | |
Secondary | Change from Baseline GCF volume at 2 months | Clinical parameter | baseline, 1st and 2nd months | |
Secondary | Change from Baseline Gingival Index at 2 months | Clinical parameter | baseline, 1st and 2nd months | |
Secondary | Change from Baseline Plaque Index at 2 months | Clinical parameter | baseline, 1st and 2nd months |
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